Influenza, Human
Conditions
Keywords
Pilot study, Safety surveillance, Quadrivalent seasonal influenza vaccine, Influenza
Brief summary
The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain). This study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in Europe.
Detailed description
The key objective of the EMA enhanced safety surveillance is to rapidly detect a significant increase in the frequency and/or severity of expected reactions (local, systemic or allergic reactions) that may indicate a potential risk. The study is a passive enhanced safety surveillance aiming to collect prospectively AEIs and/or other AEs experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine, using customized Adverse Drug Reaction cards. Data will be collected via the healthcare provide (HCP) or study medical staff who administer the seasonal influenza vaccination or who provide the inform consent form and the ADR cards.
Interventions
Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged \<9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).
Sponsors
Study design
Eligibility
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the ADR card, return for the next scheduled visit or return the ADR card by mail within a timely manner). * A male or female subject vaccinated with GSK's quadrivalent seasonal influenza vaccine (one or two dose schedule) according to the routine medical practices between 01 October 2018 and 31 December 2018. * Subjects aged 6 months or above at the time of the vaccination according to the countries' specificities. * Written informed consent/informed assent obtained from the subjects/subjects' parent(s)/Legally Acceptable Representative(s) (LARs).
Exclusion criteria
• Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders. |
| Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders. |
| Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications. |
| Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications. |
| Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations. |
| Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.There were no predefined AEIs listed on the ADR card for investigations. |
| Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders. |
| Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders. |
| Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between Intenational Organization for Standardization (ISO) weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. |
| Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. |
| Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. |
| Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. |
| Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia. |
| Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia. |
| Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity. |
| Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity. |
| Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis. |
| Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis. |
| Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was decreased appetite. |
| Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was decreased appetite. |
| Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia. |
| Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia. |
| Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache. |
| Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache. |
| Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability. |
| Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability. |
| Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing. |
| Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing. |
| Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised. |
| Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised. |
| Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders. |
| Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders. |
| Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders. |
| Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°36 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°38 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°40 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°42 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°44 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°46 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°48 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°50 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°52 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°54 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°56 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°58 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°60 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°62 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°64 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°66 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°68 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°2 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°4 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°6 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°8 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°10 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°12 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°14 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°16 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°18 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°20 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°22 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°24 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°26 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°28 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°30 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°32 for the overall (across age strata) post-dose 2 results. |
| Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°34 for the overall (across age strata) post-dose 2 results. |
| Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders. |
| Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e. week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment. |
| Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders. |
| Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders. |
| Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders. |
| Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders. |
| Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders. |
| Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications. |
| Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications. |
| Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations. |
| Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for investigations. |
| Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia. |
| Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia. |
| Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity. |
| Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. |
| Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis. |
| Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis. |
| Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card was decreased appetite. |
| Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card was decreased appetite. |
| Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia. |
| Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia. |
| Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache. |
| Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache. |
| Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability. |
| Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability. |
| Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders. |
| Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders. |
| Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing. |
| Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing. |
| Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised. |
| Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised. |
| Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. |
| Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. |
| Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. |
| Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days | The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. |
Countries
Belgium, Germany, Spain
Participant flow
Recruitment details
GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain) was administered to subjects in this study
Pre-assignment details
Subjects aged \<9 years in Vaccinated\_Fluarix Tetra Group (Spain) who were not vaccinated against influenza in preceding seasons received 2 doses of quadrivalent seasonal influenza vaccine in this study. Subjects from other groups received only 1 dose of the vaccine. Dose 2 results correspond to only some subjects in Vaccinated\_Fluarix Tetra Group.
Participants by arm
| Arm | Count |
|---|---|
| Vaccinated_AlphaRix Tetra Group Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018. | 329 |
| Vaccinated_Influsplit Tetra Group Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between
01 October and 31 December 2018. | 278 |
| Vaccinated_Fluarix Tetra Group Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between
01 October and 31 December 2018. | 453 |
| Total | 1,060 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 0 | 1 |
| Overall Study | Other | 0 | 0 | 1 |
| Overall Study | Unwilling to attend the scheduled visit | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 6 |
Baseline characteristics
| Characteristic | Vaccinated_AlphaRix Tetra Group | Vaccinated_Influsplit Tetra Group | Vaccinated_Fluarix Tetra Group | Total |
|---|---|---|---|---|
| Age, Continuous | 61.3 Years STANDARD_DEVIATION 18.2 | 65.0 Years STANDARD_DEVIATION 15.1 | 15.7 Years STANDARD_DEVIATION 18.7 | 42.8 Years STANDARD_DEVIATION 29.4 |
| Race/Ethnicity, Customized Asian - central / south asian heritage | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - east asian heritage | 4 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian - south east asian heritage | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or african american | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other, Not specified | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized White - arabic / north african heritage | 1 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized White - caucasian / european heritage | 321 Participants | 274 Participants | 444 Participants | 1039 Participants |
| Sex: Female, Male Female | 147 Participants | 166 Participants | 231 Participants | 544 Participants |
| Sex: Female, Male Male | 182 Participants | 112 Participants | 222 Participants | 516 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 329 | 0 / 278 | 0 / 453 |
| other Total, other adverse events | 139 / 329 | 102 / 278 | 227 / 453 |
| serious Total, serious adverse events | 0 / 329 | 0 / 278 | 0 / 453 |
Outcome results
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between Intenational Organization for Standardization (ISO) weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-47 | 42.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-49 | 42.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-48 | 42.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-43 | 45.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-51 | 42.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-44 | 47.12 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-52 | 42.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-45 | 43.97 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-42 | 45.39 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-50 | 42.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-46 | 42.53 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-45 | 36.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-46 | 36.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-44 | 33.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-47 | 36.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-52 | 36.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-42 | 34.31 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-50 | 36.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-48 | 36.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-40 | 32.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-51 | 36.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-49 | 36.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-43 | 34.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-41 | 34.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-48 | 47.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-42 | 44.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-43 | 46.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-44 | 42.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-45 | 46.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-46 | 45.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-47 | 46.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-49 | 47.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-50 | 47.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-51 | 47.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-52 | 47.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-49 | 43.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-45 | 42.63 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-44 | 40.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-40 | 32.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-50 | 43.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-43 | 41.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-42 | 39.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-52 | 43.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-51 | 43.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-48 | 43.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-47 | 42.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-46 | 41.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall | Week 40-41 | 34.78 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any, Weeks 40-46 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any, Weeks 40-47 | 45.45 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any, Weeks 40-48 | 44.68 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any, Weeks 40-49 | 30.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any, Weeks 40-50 | 23.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any, Weeks 40-51 | 23.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any, Weeks 40-52 | 23.74 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.09 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-46 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-47 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-48 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 1.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.92 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 1.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 1.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-51 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-50 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-49 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-45 | 0.80 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 1.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-46 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-45 | 0.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-46 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.66 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.66 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.66 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.66 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.66 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.63 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Weeks 40-47 | 0.10 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 1.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 1.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 1.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 1.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.63 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.76 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.38 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 9.09 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 2.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 1.63 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 1.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 1.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Weeks 40-47 | 9.09 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Weeks 40-50 | 1.63 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Weeks 40-51 | 1.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Weeks 40-52 | 1.44 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-45 | 1.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-44 | 1.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-46 | 1.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-47 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-43 | 2.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-48 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 5.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-44 | 3.37 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-49 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-51 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-45 | 1.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-50 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 6.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-51 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-45 | 3.90 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 6.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-52 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 6.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-46 | 3.90 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-46 | 1.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-47 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-48 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 3.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-47 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-49 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 6.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 6.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-50 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 6.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-51 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-48 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 6.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-52 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-52 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-43 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-49 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-42 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-43 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 6.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-44 | 1.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-50 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 5.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-49 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 5.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 2.48 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-50 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 2.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-51 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-52 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 5.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-42 | 1.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 5.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-43 | 1.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 5.07 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-44 | 1.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-40 | 2.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-45 | 1.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-41 | 2.48 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-46 | 1.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 5.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-47 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-48 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-42 | 3.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-49 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-50 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-51 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-52 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-43 | 3.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 4.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-44 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 5.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-45 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 4.61 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-46 | 3.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 5.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-47 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 4.41 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-48 | 3.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-43 | 4.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-44 | 4.10 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-45 | 3.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-46 | 4.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-47 | 3.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-48 | 3.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-49 | 3.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-50 | 3.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-51 | 3.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-52 | 3.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-43 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-50 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-45 | 2.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-46 | 2.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-47 | 2.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-48 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-49 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-51 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-52 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-42 | 5.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-43 | 4.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-44 | 4.10 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-45 | 3.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-46 | 2.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-47 | 2.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-48 | 3.09 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-49 | 3.09 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-50 | 3.09 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-51 | 3.09 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-52 | 3.09 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-43 | 2.31 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-45 | 0.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-46 | 0.72 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-47 | 0.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-48 | 0.66 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-49 | 0.66 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-50 | 0.66 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-51 | 0.66 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-52 | 0.66 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 8.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 7.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 5.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 6.47 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 6.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-47 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 2.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-46 | 0.30 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-45 | 0.34 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-44 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-43 | 0.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-49 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 2.48 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-48 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-47 | 3.07 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 6.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 4.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-46 | 3.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-45 | 3.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 6.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-52 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-51 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 5.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-50 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-49 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-44 | 2.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-48 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-47 | 1.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-46 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-45 | 1.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-43 | 2.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-44 | 1.73 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-43 | 1.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 6.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-42 | 1.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 5.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-52 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-42 | 2.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-51 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-50 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-41 | 2.48 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-49 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-48 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 6.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-47 | 3.07 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-46 | 2.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 5.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-45 | 2.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-44 | 2.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-40 | 2.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-43 | 2.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-42 | 2.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 6.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 6.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-52 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-51 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 6.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Weeks 40-50 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Weeks 40-51 | 0.09 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 13.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 6.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 3.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 3.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 2.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 2.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Weeks 40-46 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Weeks 40-50 | 1.63 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Weeks 40-51 | 1.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Weeks 40-52 | 1.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Weeks 40-50 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Weeks 40-50 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Weeks 40-52 | 0.72 Percentage of subjects |
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-42 | 4.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-43 | 6.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-44 | 5.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-45 | 4.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-46 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-47 | 5.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-48 | 5.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-49 | 5.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-50 | 5.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-51 | 5.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-52 | 5.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-46 | 0.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-47 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-48 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-49 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-50 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-51 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-52 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 31.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 29.07 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 31.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 27.66 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 26.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 26.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 26.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 26.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 26.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 26.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 26.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-44 | 1.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-45 | 1.42 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-46 | 1.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-47 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-48 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-49 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-50 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-51 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-52 | 1.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-42 | 2.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-43 | 2.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-44 | 4.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-45 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-46 | 3.90 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-47 | 3.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-48 | 3.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-49 | 3.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-50 | 3.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-51 | 3.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-52 | 3.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-43 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-44 | 1.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-45 | 1.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-46 | 2.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-47 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-48 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-49 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-50 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-51 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-52 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-42 | 28.37 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-43 | 26.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-44 | 25.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-45 | 21.63 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-46 | 20.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-47 | 19.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-48 | 19.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-49 | 19.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-50 | 19.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-51 | 19.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-52 | 19.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-42 | 2.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-52 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-50 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-43 | 2.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-51 | 16.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-44 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-40 | 17.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-51 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-45 | 2.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-47 | 16.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-46 | 2.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-41 | 18.01 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-52 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-47 | 2.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-48 | 2.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-40 | 8.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-49 | 2.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-41 | 8.07 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-50 | 2.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-42 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-51 | 2.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-40 | 11.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-41 | 10.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-42 | 8.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-42 | 10.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-43 | 9.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-52 | 2.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-44 | 9.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-45 | 10.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-50 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-46 | 10.87 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-43 | 8.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-47 | 10.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-48 | 10.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-49 | 10.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-50 | 16.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-50 | 10.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-44 | 8.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-43 | 16.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-51 | 10.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-52 | 10.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-40 | 2.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-41 | 1.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-42 | 0.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-49 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-43 | 0.92 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-45 | 7.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-44 | 0.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-45 | 0.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-46 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-48 | 16.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-47 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-46 | 7.61 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-48 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-48 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-49 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-50 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-44 | 15.95 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-51 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-51 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-47 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-47 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-52 | 16.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-48 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-45 | 17.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-41 | 6.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-46 | 1.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-42 | 6.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-49 | 16.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-49 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-45 | 1.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-43 | 7.37 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 25.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 27.95 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-44 | 7.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 27.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 26.73 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-50 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-45 | 8.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 26.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 28.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-46 | 7.97 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 27.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 27.70 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-46 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 27.70 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-47 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-51 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 27.70 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-52 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 27.70 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-48 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 27.70 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 27.70 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-49 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-41 | 1.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-45 | 0.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-46 | 0.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-47 | 0.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-48 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-49 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-50 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-51 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-52 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 24.10 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 28.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 28.06 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 29.06 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 30.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 30.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 30.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 30.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 30.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-43 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-44 | 2.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-45 | 2.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-46 | 2.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-47 | 2.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-48 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-49 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-50 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-51 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-52 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-43 | 0.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-43 | 6.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-44 | 7.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-45 | 6.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-46 | 7.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-47 | 7.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-48 | 7.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-49 | 7.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-50 | 7.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-51 | 7.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-52 | 7.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-42 | 5.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-43 | 6.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-44 | 6.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-45 | 5.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-46 | 5.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-47 | 5.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-48 | 5.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-49 | 5.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-50 | 5.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-51 | 5.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-52 | 5.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-42 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-43 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-44 | 8.72 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-45 | 13.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-46 | 14.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-47 | 15.10 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-48 | 16.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-49 | 16.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-50 | 16.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-51 | 16.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-52 | 16.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-42 | 5.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-43 | 6.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-44 | 5.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-45 | 5.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-46 | 6.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-47 | 6.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-48 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-49 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-50 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-51 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-52 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-42 | 5.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-43 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-44 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-45 | 6.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-46 | 6.47 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-47 | 6.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-48 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-49 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-50 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-51 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-52 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-52 | 17.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-51 | 17.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-50 | 17.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-49 | 17.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-48 | 17.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-47 | 16.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-46 | 16.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-45 | 17.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-51 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-44 | 16.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-43 | 17.92 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-46 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-42 | 20.65 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-41 | 18.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-45 | 0.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Weeks 40-40 | 17.14 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-52 | 5.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-51 | 5.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-50 | 5.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-52 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-49 | 5.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-48 | 5.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-47 | 5.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-46 | 5.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-45 | 4.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-44 | 5.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-43 | 5.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-42 | 5.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-41 | 8.07 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Weeks 40-40 | 8.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-52 | 6.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-51 | 6.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-50 | 6.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-49 | 6.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-48 | 6.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-47 | 6.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-46 | 6.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-45 | 6.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-46 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-44 | 6.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-43 | 5.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-42 | 5.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-41 | 6.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Weeks 40-40 | 5.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-46 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-45 | 0.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-44 | 0.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-52 | 2.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-51 | 2.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-50 | 2.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-49 | 2.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-48 | 2.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-47 | 2.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-46 | 2.30 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-45 | 2.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-44 | 2.05 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-43 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-42 | 1.76 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-41 | 1.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 28.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 28.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 28.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 28.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 28.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 27.97 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 27.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 27.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 27.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 27.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 28.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 27.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 25.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-44 | 0.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-46 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-45 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-46 | 0.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-47 | 0.48 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-52 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-51 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-50 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-49 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-48 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-47 | 3.07 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-46 | 3.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-45 | 2.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-48 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-44 | 2.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-43 | 2.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-42 | 1.26 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-41 | 1.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Weeks 40-40 | 2.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-52 | 7.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-51 | 7.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-50 | 7.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-49 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-49 | 7.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-48 | 7.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-47 | 7.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-46 | 6.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-45 | 6.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-44 | 6.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-43 | 7.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-42 | 7.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Weeks 40-50 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-41 | 10.56 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Weeks 40-40 | 11.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Weeks 40-41 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 8.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 8.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 31.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 17.02 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 11.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 9.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Weeks 40-47 | 27.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Weeks 40-48 | 14.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Weeks 40-49 | 8.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Weeks 40-50 | 5.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Weeks 40-51 | 5.19 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Weeks 40-52 | 5.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Weeks 40-47 | 9.09 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Weeks 40-48 | 6.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Weeks 40-49 | 4.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Weeks 40-50 | 4.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Weeks 40-51 | 4.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Weeks 40-52 | 5.04 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hypersensitivity,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Anaphylactic reaction,Weeks 40-46 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-49 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 1.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-50 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 4.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-51 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-45 | 3.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-52 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-47 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 4.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 4.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-43 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 4.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-44 | 1.92 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-45 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-46 | 3.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-46 | 1.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-47 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 4.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-48 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 2.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-49 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-48 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-50 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-43 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-51 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 4.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-52 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 4.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-44 | 1.92 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-42 | 3.92 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-43 | 4.15 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 7.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-44 | 3.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-45 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-46 | 3.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-47 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 8.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-40 | 8.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-48 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-49 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-50 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-51 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 7.97 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-52 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 7.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-41 | 5.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-42 | 4.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-43 | 4.61 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-44 | 4.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-45 | 5.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-46 | 4.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-47 | 4.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-48 | 4.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-49 | 4.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-50 | 4.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-51 | 4.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-52 | 4.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 7.83 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-41 | 8.70 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-41 | 3.73 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 4.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 5.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 5.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 6.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 6.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-43 | 0.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-44 | 1.03 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-45 | 2.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-46 | 2.64 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-47 | 2.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-48 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-49 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-50 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-51 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-52 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-43 | 2.31 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-44 | 2.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-45 | 2.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-46 | 2.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-47 | 2.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-48 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-49 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-50 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-51 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-52 | 2.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-43 | 0.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-52 | 0.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-42 | 2.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-41 | 3.73 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 4.82 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-40 | 4.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 6.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 4.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Ear infection,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 6.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 6.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Nasopharyngitis,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 6.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Bronchitis,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-52 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 6.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-51 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-50 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-49 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-48 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-47 | 3.07 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-46 | 3.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 6.13 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-45 | 3.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-44 | 3.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 5.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-43 | 2.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-42 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-41 | 8.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-41 | 5.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Rhinitis,Weeks 40-40 | 4.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-52 | 3.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-51 | 3.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 5.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Oral herpes,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-50 | 3.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-49 | 3.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-48 | 3.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-47 | 3.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 5.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-46 | 3.30 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-45 | 2.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-40 | 8.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Hordeolum,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-44 | 2.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Conjunctivitis,Weeks 40-43 | 2.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Upper respiratory tract infection,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Laryngitis,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Herpes simplex,Weeks 40-46 | 0.10 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 6.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 3.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 3.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 2.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 2.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Weeks 40-48 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Weeks 40-49 | 2.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Weeks 40-50 | 2.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Weeks 40-51 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Weeks 40-52 | 2.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Weeks 40-50 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Weeks 40-52 | 0.72 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 1.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 1.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 1.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-42 | 0.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-43 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-44 | 1.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-45 | 1.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-46 | 1.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-47 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-48 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-49 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-50 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-51 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-52 | 1.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-46 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-47 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-52 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-51 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-42 | 0.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-43 | 0.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-49 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-50 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-44 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-48 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Weeks 40-45 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.38 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.There were no predefined AEIs listed on the ADR card for investigations.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was decreased appetite.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 0.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 1.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 1.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-44 | 0.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-45 | 1.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-46 | 1.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-47 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-49 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-50 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-51 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-52 | 2.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 6.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-50 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 8.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-43 | 8.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-44 | 8.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-52 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-45 | 6.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 8.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-46 | 5.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-51 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 5.03 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-47 | 5.03 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-49 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-48 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 5.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 5.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 5.30 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-52 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-46 | 2.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-46 | 2.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-51 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-47 | 2.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-42 | 1.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-51 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-47 | 2.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-52 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-42 | 1.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-44 | 2.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-50 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-48 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-43 | 2.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-50 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-43 | 2.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-49 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-44 | 2.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-45 | 3.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-45 | 3.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Decreased appetite,Weeks 40-48 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall | Any,Weeks 40-49 | 3.02 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was decreased appetite.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 2.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 2.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 2.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Weeks 40-48 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Weeks 40-49 | 2.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Weeks 40-50 | 2.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Weeks 40-51 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Weeks 40-52 | 2.16 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-46 | 8.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-45 | 8.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-44 | 8.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-43 | 8.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-42 | 9.93 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-52 | 3.34 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-51 | 3.34 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-50 | 3.34 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-52 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-49 | 3.34 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-48 | 3.34 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-47 | 3.34 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-46 | 3.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-51 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-45 | 3.19 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-44 | 3.37 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-43 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-42 | 1.42 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 10.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 10.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 10.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 10.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-50 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 10.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-49 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 10.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 11.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 10.99 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 11.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 9.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-48 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 11.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-47 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-45 | 0.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-46 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-47 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-48 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-49 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-50 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-51 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-46 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-47 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-48 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-49 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-50 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-51 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 6.83 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 5.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 6.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 6.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 7.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-41 | 1.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-42 | 1.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-43 | 2.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-44 | 2.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-45 | 3.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-46 | 3.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-47 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-48 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-49 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-50 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-51 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-52 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-41 | 5.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-42 | 4.41 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-43 | 4.61 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-44 | 4.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-45 | 5.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-46 | 5.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-47 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-48 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-49 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-50 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-51 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-52 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 8.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-49 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-49 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 8.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-50 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-51 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 8.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-52 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-43 | 0.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 8.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 8.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-50 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 6.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-48 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 7.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-51 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-43 | 6.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-46 | 6.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 7.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-45 | 1.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-47 | 5.95 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-44 | 5.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-46 | 1.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 7.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-47 | 1.83 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-52 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-45 | 5.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-48 | 2.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-43 | 6.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-44 | 5.98 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-44 | 0.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-45 | 6.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-46 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-46 | 6.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-43 | 0.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 5.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 6.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-47 | 6.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 8.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 7.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 8.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 8.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-48 | 6.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 8.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 8.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 9.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 9.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-49 | 6.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 9.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 9.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 9.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-50 | 6.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-41 | 1.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-42 | 1.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-43 | 1.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-44 | 2.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-51 | 6.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-45 | 2.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-46 | 2.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-47 | 2.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-48 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-52 | 6.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-49 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-47 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-50 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-51 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-46 | 0.30 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Weeks 40-52 | 3.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-40 | 5.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-41 | 5.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Weeks 40-42 | 6.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Weeks 40-45 | 0.34 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Weeks 40-49 | 0.09 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Weeks 40-50 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Weeks 40-52 | 0.72 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-47 | 7.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-45 | 8.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-42 | 4.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-43 | 5.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-52 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 8.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-48 | 7.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-51 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-49 | 7.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 5.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-50 | 7.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-52 | 7.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 8.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-51 | 7.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-50 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-49 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-44 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 8.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-48 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-47 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-46 | 0.97 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-45 | 1.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-46 | 7.79 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 9.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 6.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 6.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-46 | 7.25 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 7.61 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 6.83 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-45 | 6.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-41 | 6.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-42 | 5.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-43 | 5.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-44 | 6.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-48 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-49 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-50 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-51 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-52 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 6.37 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 7.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 6.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-47 | 7.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 6.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-46 | 6.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 4.10 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-51 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-50 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-52 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 7.95 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-49 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 7.95 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-48 | 7.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 7.95 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-47 | 6.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-43 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 6.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-45 | 5.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 7.95 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-44 | 4.10 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 6.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 7.95 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 6.95 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 5.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 6.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 5.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 6.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 6.30 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 7.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 7.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 7.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 8.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 8.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 8.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 8.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 8.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-40 | 4.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-45 | 6.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-46 | 6.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-44 | 5.98 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-41 | 6.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-42 | 5.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-43 | 5.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-47 | 6.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-48 | 7.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-49 | 7.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-50 | 7.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-51 | 7.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Weeks 40-52 | 7.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-45 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-46 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-47 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-48 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-49 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-50 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-51 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Weeks 40-52 | 0.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Weeks 40-51 | 0.09 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-46 | 0.97 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-47 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-48 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-49 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-50 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.97 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-51 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-52 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-45 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 2.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-42 | 1.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-43 | 1.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-44 | 1.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-45 | 1.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-46 | 1.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-47 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 2.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-48 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-49 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-50 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-51 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 1.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-52 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 1.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 3.59 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 2.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 2.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 2.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-43 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-44 | 3.59 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-45 | 2.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-46 | 2.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-47 | 2.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-48 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-49 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-50 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-51 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-52 | 2.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 1.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-52 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-51 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-50 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-49 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-48 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-47 | 1.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 2.05 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-46 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-45 | 1.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-44 | 1.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-43 | 1.73 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-42 | 1.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 1.26 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 1.82 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 4.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 3.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 2.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 2.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Weeks 40-48 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Weeks 40-49 | 4.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Weeks 40-50 | 3.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Weeks 40-51 | 2.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Weeks 40-52 | 2.88 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 14.59 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-46 | 3.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 14.59 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 14.59 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 14.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 15.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-47 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 13.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 11.63 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-48 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-49 | 1.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 9.93 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-49 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-50 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-51 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-52 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-47 | 1.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-42 | 3.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-43 | 5.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-52 | 9.12 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-44 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-51 | 9.12 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-50 | 9.12 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-45 | 9.93 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-49 | 9.12 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-48 | 9.12 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-46 | 9.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-47 | 9.12 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-50 | 1.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-46 | 0.97 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-51 | 1.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-42 | 2.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-43 | 2.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-52 | 1.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-44 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-45 | 3.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-46 | 3.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-47 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-48 | 1.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-48 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-45 | 1.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-49 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-44 | 1.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-43 | 1.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-50 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-42 | 1.42 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-52 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-51 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-51 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-50 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-52 | 3.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-49 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-48 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-47 | 3.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-46 | 3.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-42 | 3.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-45 | 3.90 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-44 | 3.37 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-43 | 3.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-43 | 3.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-42 | 2.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-44 | 3.37 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 14.59 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 14.59 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-45 | 3.19 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 14.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-52 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-46 | 3.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-47 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-48 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-49 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-50 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-51 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-52 | 3.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-41 | 1.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-42 | 1.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-43 | 1.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-44 | 1.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-45 | 1.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-46 | 1.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-47 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-48 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-49 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-50 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-51 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-52 | 1.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-41 | 3.73 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-42 | 3.92 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-43 | 4.15 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-44 | 4.31 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-45 | 4.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-46 | 3.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-47 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-48 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-49 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-50 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-51 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-52 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-41 | 5.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-42 | 5.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-43 | 5.53 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-44 | 5.17 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-45 | 5.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-47 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-48 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-49 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-50 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-51 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-52 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-41 | 5.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-42 | 5.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-43 | 5.53 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-44 | 5.17 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-45 | 5.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-46 | 5.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-47 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-48 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-49 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-50 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-51 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-52 | 5.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-43 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-44 | 1.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-46 | 5.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 8.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 11.18 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 10.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 11.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 11.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 12.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 11.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 11.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 11.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 11.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 11.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 11.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 11.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-40 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-41 | 4.35 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-42 | 4.41 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-43 | 4.15 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-44 | 3.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-45 | 4.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-46 | 3.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-47 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-48 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-49 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-50 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-51 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-52 | 3.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-41 | 2.48 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-42 | 3.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-43 | 3.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-44 | 3.02 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-45 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-42 | 0.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-43 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-44 | 1.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-45 | 1.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-46 | 1.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-47 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-48 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-49 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-50 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-51 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-52 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-45 | 1.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-46 | 1.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-47 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-48 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-49 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-50 | 1.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-51 | 1.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-49 | 2.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-51 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 22.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-45 | 4.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 22.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 22.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-44 | 4.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-46 | 2.40 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 22.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-52 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-47 | 0.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-42 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-43 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-43 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-44 | 14.36 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-45 | 10.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-46 | 10.55 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-47 | 10.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-48 | 10.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-52 | 8.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-49 | 10.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-50 | 10.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-51 | 8.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-51 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-51 | 10.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-52 | 10.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-50 | 8.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-48 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-43 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-49 | 8.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-44 | 2.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-45 | 2.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-48 | 8.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-47 | 8.01 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-48 | 2.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-46 | 8.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-45 | 8.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-44 | 10.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-52 | 2.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-43 | 10.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-49 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-42 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-43 | 0.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-51 | 2.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-45 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-52 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-46 | 0.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-47 | 0.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-51 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-48 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-49 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-50 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-50 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-51 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-49 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-50 | 2.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-50 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-52 | 0.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-48 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-46 | 9.83 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-47 | 10.07 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-43 | 0.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-48 | 10.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-45 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-49 | 10.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-50 | 10.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-44 | 9.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-51 | 10.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-44 | 1.03 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-52 | 10.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-47 | 0.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-43 | 9.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-45 | 0.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-45 | 0.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-44 | 1.03 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-46 | 0.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-52 | 5.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-46 | 0.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-51 | 5.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-47 | 0.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-50 | 5.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-47 | 2.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-49 | 5.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-48 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-45 | 1.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-46 | 0.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-49 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-48 | 5.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 26.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-47 | 5.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 23.59 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-50 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 22.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-46 | 5.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 22.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-52 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 22.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 22.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 17.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-49 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-45 | 0.34 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-41 | 3.73 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 15.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-44 | 0.94 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-40 | 5.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-41 | 5.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-52 | 0.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-52 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-46 | 0.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-47 | 2.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-45 | 0.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-51 | 0.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-40 | 4.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 17.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 17.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-45 | 4.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-50 | 0.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 17.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-50 | 2.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 17.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-44 | 4.41 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-43 | 0.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 17.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-52 | 4.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-46 | 2.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-46 | 0.30 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 17.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-40 | 7.14 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-41 | 4.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-43 | 4.82 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-49 | 0.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-42 | 5.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-43 | 6.74 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-42 | 4.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-47 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-48 | 4.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-44 | 6.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-46 | 0.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-45 | 6.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-41 | 5.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 17.08 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-46 | 6.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-40 | 5.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-48 | 2.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-47 | 6.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-52 | 5.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-48 | 6.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-48 | 0.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-51 | 4.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-49 | 6.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-51 | 5.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-42 | 0.76 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-49 | 2.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-50 | 6.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 8.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-46 | 8.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-51 | 6.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-50 | 5.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Weeks 40-52 | 6.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-40 | 4.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 15.91 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-41 | 2.48 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-47 | 8.52 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-45 | 8.73 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 11.18 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-42 | 2.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-49 | 5.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-46 | 4.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-48 | 8.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-43 | 2.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-44 | 2.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-48 | 5.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-41 | 1.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-50 | 4.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-45 | 2.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-49 | 8.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-48 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-44 | 7.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-47 | 0.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-47 | 5.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-47 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-42 | 0.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-50 | 8.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-50 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-43 | 0.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-46 | 5.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-51 | 8.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-44 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-43 | 6.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-45 | 0.34 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-45 | 5.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-52 | 2.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-45 | 1.02 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-46 | 0.30 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-52 | 8.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-51 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Weeks 40-44 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-47 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-44 | 5.98 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 12.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-43 | 5.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-49 | 4.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Weeks 40-47 | 4.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-42 | 0.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Weeks 40-42 | 5.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Weeks 40-44 | 0.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Weeks 40-42 | 5.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Weeks 40-43 | 0.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Weeks 40-51 | 2.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Weeks 40-41 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 13.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 25.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 18.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 13.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 14.07 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 13.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Weeks 40-47 | 13.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Weeks 40-48 | 17.02 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Weeks 40-49 | 13.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Weeks 40-50 | 10.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Weeks 40-51 | 9.63 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Weeks 40-52 | 9.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Weeks 40-48 | 6.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Weeks 40-49 | 3.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Weeks 40-50 | 2.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Weeks 40-51 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Weeks 40-52 | 2.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Weeks 40-50 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Weeks 40-48 | 6.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Weeks 40-49 | 4.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Weeks 40-50 | 3.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Weeks 40-51 | 2.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Weeks 40-52 | 2.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Weeks 40-48 | 12.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Weeks 40-49 | 9.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Weeks 40-50 | 7.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Weeks 40-51 | 7.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Weeks 40-52 | 7.19 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Weeks 40-47 | 4.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Weeks 40-48 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Weeks 40-49 | 2.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Weeks 40-50 | 1.63 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Weeks 40-51 | 1.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Weeks 40-52 | 1.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Weeks 40-52 | 0.72 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-47 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-52 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-45 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-51 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-51 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-50 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-52 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-49 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-49 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-48 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-47 | 0.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-46 | 0.97 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-45 | 1.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-50 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-48 | 0.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 1.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-46 | 0.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-45 | 1.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-44 | 1.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-43 | 1.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-42 | 1.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 2.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-41 | 1.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 1.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 2.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-41 | 0.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-42 | 0.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-43 | 0.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-44 | 0.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-45 | 0.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 2.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 2.17 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-52 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-52 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 1.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-51 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-50 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-49 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-46 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-48 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-47 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-48 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 2.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-47 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-49 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-50 | 0.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-46 | 1.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-51 | 0.36 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 2.05 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 1.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 1.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 1.37 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 1.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 1.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 1.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 1.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 1.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-43 | 0.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-45 | 1.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-46 | 0.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-47 | 0.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-48 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-49 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-50 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-51 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-52 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-43 | 0.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-44 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-45 | 0.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-46 | 0.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-47 | 0.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-48 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-49 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-50 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-51 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-52 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-45 | 0.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-42 | 0.76 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-43 | 0.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-44 | 0.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-45 | 0.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-46 | 0.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-47 | 0.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 1.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-48 | 0.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 1.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-49 | 0.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 1.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-50 | 0.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-51 | 0.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-52 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-51 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-52 | 0.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-50 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-49 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-48 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-47 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 1.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-46 | 0.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-45 | 0.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 2.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-44 | 0.63 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-43 | 0.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-42 | 0.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-41 | 0.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 1.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-45 | 0.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 1.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Weeks 40-46 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-52 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-51 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-50 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-49 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 1.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-48 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-40 | 1.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-47 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Weeks 40-41 | 1.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Weeks 40-46 | 0.20 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-50 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Weeks 40-48 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Weeks 40-49 | 1.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Weeks 40-50 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Weeks 40-51 | 0.74 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Weeks 40-52 | 0.72 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Weeks 40-52 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-43 | 0.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-44 | 0.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-45 | 0.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-46 | 0.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-47 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-48 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-49 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-50 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-51 | 0.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-52 | 0.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-46 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-51 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-52 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-42 | 0.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-50 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-43 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-49 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-44 | 0.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-47 | 0.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-45 | 0.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Weeks 40-48 | 0.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Weeks 40-49 | 0.09 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°2 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 39.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 47.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 39.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 39.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 39.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 39.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 39.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 40.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 42.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 47.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 40.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 29.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 46.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 46.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 46.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 46.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 46.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 46.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 45.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 45.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 46.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 47.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 28.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 46.15 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 43.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 44.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 44.05 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 44.32 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 47.92 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 48.18 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 48.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 48.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 48.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 48.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 48.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 48.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 28.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 27.64 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 28.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 27.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 28.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 28.92 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 28.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 28.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 28.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 28.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 28.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 52.63 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 43.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 52.63 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 52.63 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 45.72 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 42.11 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 60.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 45.72 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 44.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 46.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 56.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 42.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 45.72 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 52.63 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 52.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 52.63 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 45.72 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 43.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 52.63 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 45.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 42.48 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 44.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 34.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 43.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 46.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 34.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 46.34 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 45.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 35.41 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 45.97 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 43.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 46.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 45.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 49.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 34.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 48.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 45.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 49.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 34.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 49.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 45.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 34.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 49.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 42.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 49.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 45.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 49.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 34.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 49.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 25.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 34.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 28.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 43.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 34.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 27.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 46.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 31.46 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 41.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 41.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 41.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 41.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 41.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 48.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 56.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 41.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 41.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 51.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 43.95 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 37.93 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 34.62 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 35.34 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 34.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 32.35 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 35.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 35.34 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 35.61 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 35.34 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 35.34 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 36.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 35.48 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 37.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 37.93 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 32.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 35.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 37.93 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 34.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 35.34 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 37.93 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 35.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 37.93 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 35.34 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 37.93 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 48.10 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 56.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 45.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 41.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 43.94 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 43.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 44.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 45.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 45.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 45.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 45.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 51.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 45.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 49.34 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 47.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 49.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 49.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 49.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 49.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 49.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 38.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 44.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 42.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 41.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 39.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 43.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 42.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 42.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 43.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 42.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 42.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 40.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 43.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 42.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 34.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 42.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 35.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 41.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 41.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 34.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 42.41 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 39.65 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 43.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 42.14 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 43.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 40.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 43.21 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 57.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 53.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 34.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 29.73 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 28.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 29.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 50.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 40.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 41.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 29.09 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 20.93 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 21.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 20.88 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°24 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 1.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 1.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 1.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 1.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 1.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 3.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 1.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.28 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 1.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 1.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.88 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.26 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°26 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.66 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 1.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 3.64 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 1.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 1.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 3.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 1.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 1.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.75 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 1.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 3.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.36 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.31 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 1.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 1.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 1.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 1.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 1.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 1.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 1.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.56 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 1.14 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 1.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.66 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 1.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.55 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 1.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 1.39 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 2.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 1.25 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 1.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 1.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 1.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.66 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.97 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.41 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.88 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.91 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.26 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 2.13 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.89 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°28 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.66 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 1.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 1.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 2.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 2.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 1.95 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 1.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 1.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 1.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 2.14 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 1.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 1.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 1.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 1.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 1.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 1.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 1.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 1.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 2.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 2.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 2.22 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 1.75 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 1.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 1.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 1.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.88 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.26 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 1.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.58 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 14.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 2.08 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 1.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 1.10 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 6.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 1.82 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°4 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 10.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 1.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 10.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 10.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 10.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 10.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 10.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 10.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 10.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 11.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 8.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 5.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 1.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 1.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 1.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 1.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 1.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 1.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 1.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 1.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 1.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 1.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 3.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 1.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 3.70 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 4.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 5.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 7.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 7.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 7.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 7.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 7.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 7.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 7.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 7.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 3.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 4.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 4.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 4.17 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 3.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 3.61 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 3.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 3.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 3.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 3.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 3.59 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 6.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 6.81 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 6.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 6.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 7.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 6.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 7.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 8.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 2.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 6.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 7.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 6.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 6.31 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 6.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 7.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 6.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 6.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 7.08 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 6.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 7.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 6.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 1.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 3.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 7.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 2.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 7.08 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 7.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 2.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 6.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 3.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 7.08 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 3.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 7.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 4.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 7.08 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 4.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 7.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 4.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 7.08 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 7.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 4.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 6.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 4.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 7.08 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 4.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 7.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 4.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 2.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 7.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 3.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 6.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 7.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 5.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 8.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 5.62 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 10.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 12.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 10.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 12.05 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 10.83 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 10.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 10.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 10.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 10.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 10.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 10.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 6.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 2.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 2.63 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 2.42 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 2.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 2.31 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 2.94 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 3.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 2.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 7.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 7.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 7.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 7.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 5.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 8.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 6.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 5.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 9.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 6.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 6.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 6.06 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 8.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 6.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 6.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 6.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 7.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 6.61 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 7.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 6.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 6.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 7.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 7.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 6.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 7.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 8.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 7.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 4.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 8.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 4.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 2.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 8.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 2.63 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 4.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 8.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 4.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 2.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 9.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 8.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 8.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 3.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 4.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 8.05 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 4.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 3.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 8.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 2.13 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 3.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 4.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 8.21 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 14.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 5.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 4.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 4.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 50.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 13.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 5.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 3.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 2.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 2.20 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°6 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 22.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 33.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 22.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 22.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 22.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 22.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 22.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 23.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 24.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 30.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 20.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 17.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 32.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 32.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 32.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 32.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 32.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 32.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 31.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 31.30 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 32.03 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 32.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 19.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 42.31 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 38.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 39.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 39.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 39.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 41.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 40.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 40.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 40.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 40.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 40.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 40.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 40.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 15.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 20.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 19.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 18.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 18.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 19.48 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 19.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 19.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 19.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 19.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 19.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 19.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 40.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 25.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 40.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 40.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 26.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 23.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 40.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 26.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 43.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 23.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 26.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 40.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 39.64 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 40.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 26.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 23.83 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 40.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 26.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 23.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 26.92 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 22.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 38.81 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 42.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 21.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 35.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 26.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 21.97 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 35.07 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 23.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 35.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 26.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 37.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 21.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 36.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 26.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 37.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 21.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 37.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 26.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 21.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 37.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 23.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 37.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 26.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 37.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 21.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 37.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 15.91 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 21.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 20.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 25.08 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 21.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 19.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 26.92 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 19.10 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e. week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 24.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 24.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 24.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 24.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 24.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 24.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 25.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 32.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 25.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 24.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 37.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 28.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 27.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 28.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 28.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 28.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 28.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 28.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 28.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 28.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 28.35 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 27.07 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 26.87 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 28.95 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 29.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 25.53 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 24.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 24.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 27.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 27.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 27.07 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 27.07 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 27.07 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 27.07 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 27.07 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 34.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 25.99 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 43.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 32.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 26.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 26.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 19.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 26.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 26.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 34.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 24.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 26.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 32.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 34.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 22.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 26.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 24.73 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 34.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 24.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 34.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 32.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 31.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 28.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 28.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 26.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 28.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 28.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 28.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 26.92 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 25.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 28.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 29.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 27.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 26.44 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 28.42 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 27.76 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 27.37 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 28.37 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 28.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 27.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 27.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 28.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 28.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 28.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 28.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 28.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 28.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 28.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 15.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 11.54 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 10.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 8.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 10.42 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 17.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 10.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 8.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 8.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 8.79 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°8 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.66 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.18 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.18 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.18 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.18 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.18 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.18 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°10 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 7.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 7.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 7.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 7.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 7.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 7.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 7.34 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 7.95 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 6.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 4.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 5.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 11.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 11.94 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 9.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 10.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 11.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 11.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 10.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 10.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 10.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 10.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 10.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 10.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 10.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 6.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 6.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 6.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 6.02 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 5.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 6.02 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 5.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 5.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 5.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 5.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 5.99 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 8.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 5.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 8.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 8.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 5.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 4.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 5.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 8.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 4.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 5.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 8.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 9.01 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 8.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 5.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 4.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 8.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 5.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 4.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 1.92 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 5.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 11.94 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 11.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 6.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 4.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 5.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 6.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 4.74 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 4.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 4.98 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 5.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 6.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 6.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 6.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 5.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 6.42 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 6.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 6.42 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 5.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 6.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 6.42 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 4.74 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 6.42 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 5.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 6.42 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 6.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 6.42 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 6.82 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 6.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 6.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 5.26 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 6.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 5.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 3.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 5.62 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 6.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 4.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 6.02 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 7.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 7.10 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 6.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 6.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 6.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 6.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 6.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 8.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 8.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 8.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 7.87 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 8.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 7.64 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 8.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 7.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 7.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 7.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 7.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 5.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 5.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 3.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 4.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 4.55 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 4.61 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 7.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 7.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 5.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 7.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 7.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 7.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 7.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 7.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 7.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 7.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 4.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 7.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 4.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 8.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 6.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 8.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 4.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 7.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 4.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 3.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 6.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 7.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 7.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 4.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 4.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 6.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 4.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 4.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 7.09 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 8.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 4.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 4.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 7.50 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 23.08 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 11.54 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 8.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 6.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 6.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 1.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 1.10 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°30 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 1.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°32 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.66 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 1.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 2.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 2.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 1.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 1.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.75 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.60 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.66 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.56 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.56 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.56 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.56 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.56 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.56 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.56 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.49 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 2.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 2.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 3.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 2.94 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 2.63 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.73 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 1.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.71 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°12 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.79 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 2.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 2.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 1.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 1.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 1.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 1.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 1.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 1.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 6.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 8.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 7.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 1.37 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 7.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 6.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 6.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 6.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 6.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 6.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 6.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.88 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.98 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 1.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 6.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 6.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 1.31 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 6.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 1.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 6.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 6.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 1.65 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 6.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 6.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 1.65 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 7.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.84 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 1.65 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 1.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 1.65 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 1.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 7.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 1.65 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 8.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 3.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 1.65 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 3.43 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 6.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 2.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 3.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 3.28 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 3.43 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 3.43 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 3.43 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 3.43 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 3.43 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.74 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 6.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 2.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 5.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 9.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 7.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 6.06 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 5.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 4.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 5.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 5.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 5.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 3.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 2.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 3.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 2.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 1.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.88 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 2.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 3.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 2.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 3.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 3.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 3.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 2.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 2.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 1.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 2.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 2.82 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 3.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 2.83 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 2.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 3.39 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 2.08 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 6.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 5.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 3.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 2.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 2.20 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°14 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 12.90 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 12.03 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 9.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 9.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 9.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 9.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 9.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 9.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 10.17 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 9.93 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 8.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 12.03 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 12.03 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 12.03 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 12.03 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 12.03 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 12.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 12.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 12.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 12.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 7.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 8.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 7.41 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 7.95 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 9.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 9.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 9.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 9.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 9.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 9.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 6.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 5.32 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 4.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 6.25 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 7.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 7.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 7.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 7.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 7.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 7.19 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 6.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 4.95 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 6.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 14.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 5.79 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 6.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 5.05 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 14.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 4.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 15.07 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 14.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 6.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 14.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 14.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 6.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 14.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 14.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 7.14 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 3.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 5.05 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 8.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 8.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 10.73 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 6.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 8.52 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 10.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 10.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 6.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 7.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 11.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 8.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 12.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 6.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 8.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 5.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 12.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 8.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 12.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 6.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 12.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 12.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 12.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 4.95 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 8.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 12.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 7.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 6.82 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 8.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 5.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 8.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 4.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 4.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 5.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 6.49 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 9.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 6.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 9.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 10.19 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 10.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 9.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 9.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 9.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 9.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 9.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 12.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 6.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 9.66 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 9.66 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 6.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 5.97 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 8.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 9.66 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 8.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 8.66 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 8.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 8.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 9.66 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 9.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 9.66 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 2.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 2.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 4.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 9.66 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 4.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 6.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 7.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 5.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 6.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 8.11 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 7.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 5.93 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 6.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 6.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 6.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 6.91 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 6.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 7.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 9.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 7.05 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 9.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 6.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 6.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 9.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 9.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 8.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 9.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 9.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 8.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 9.05 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 9.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 9.05 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 5.97 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 4.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 8.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 9.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 8.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 9.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 9.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 6.94 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 9.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 9.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 9.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 9.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 4.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 9.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 8.72 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 8.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 2.13 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 8.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 9.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 9.11 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 6.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 1.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 1.10 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°16 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 10.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 4.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 10.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 10.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 10.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 10.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 10.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 11.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 13.91 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 13.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 11.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 11.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 4.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 4.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 4.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 4.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 4.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 4.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 4.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 4.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 4.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 4.72 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 4.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 10.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 8.64 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 9.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 10.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 10.42 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 12.73 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 13.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 13.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 13.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 13.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 13.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 13.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 4.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 4.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 4.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 4.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 4.17 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 4.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 4.22 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 4.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 4.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 4.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 4.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 4.19 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 4.64 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 6.19 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 4.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 6.19 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 13.70 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 4.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 6.19 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 13.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 6.19 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 4.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 6.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 4.58 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 1.92 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 7.59 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 10.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 7.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 7.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 6.34 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 6.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 9.18 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 6.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 4.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 6.79 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 6.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 8.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 8.16 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 9.94 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 6.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 10.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 7.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 10.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 6.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 7.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 10.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 4.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 10.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 6.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 10.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 7.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 10.06 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 4.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 7.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 4.26 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 4.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 7.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 5.71 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 5.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 6.18 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 11.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 14.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 15.66 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 14.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 12.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 11.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 11.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 11.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 11.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 11.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 3.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 3.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 5.97 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 6.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 5.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 5.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 5.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 5.88 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 6.94 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 8.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 7.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 7.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 7.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 7.84 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 7.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 6.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 2.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 7.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 5.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 3.70 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 7.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 6.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 6.91 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 7.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 6.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 8.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 7.05 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 8.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 7.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 7.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 8.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 8.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 7.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 8.52 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 9.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 9.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 5.97 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 9.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 6.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 5.97 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 8.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 6.14 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 6.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 8.78 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 6.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 4.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 9.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 9.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 9.46 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 4.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 6.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 9.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 6.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 4.10 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 9.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 8.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 5.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 6.40 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 9.46 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°18 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 1.32 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 1.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 1.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 1.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 1.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 1.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 1.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 1.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 1.53 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 1.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 1.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 2.41 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 1.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 1.04 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 2.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 3.01 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 2.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 2.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 2.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 2.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 2.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 2.40 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 2.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 2.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 3.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 3.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 3.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 3.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 3.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 3.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 2.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 3.27 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 3.41 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 1.92 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 3.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 3.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 3.27 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 3.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 3.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 3.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 2.23 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 3.41 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 2.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 2.14 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 1.93 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 2.25 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 2.04 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 1.97 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 3.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 3.24 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 1.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 1.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 1.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 1.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 1.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 1.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 1.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 1.47 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 3.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 3.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 3.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 3.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 3.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 3.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 3.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 5.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 4.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 4.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.66 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 2.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 3.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 5.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 4.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 3.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 3.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 3.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 3.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 1.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 1.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 3.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 1.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 3.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 3.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 1.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 1.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 1.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 1.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 1.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 1.94 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 1.65 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 1.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 1.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 3.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 1.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 2.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 1.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 2.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 1.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 1.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 1.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 1.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 2.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 1.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 1.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 1.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 1.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 1.60 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 1.96 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 5.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 7.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 4.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 4.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 4.40 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°20 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 17.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 9.68 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 17.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 17.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 17.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 17.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 17.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 18.64 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 20.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 20.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 15.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 11.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 9.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 9.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 9.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 9.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 9.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 9.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 9.92 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 9.92 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 10.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 10.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 7.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 16.42 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 16.05 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 17.05 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 17.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 17.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 17.12 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 17.12 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 17.12 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 17.12 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 17.12 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 17.12 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 4.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 7.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 7.32 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 8.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 7.64 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 8.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 7.83 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 7.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 7.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 7.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 7.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 7.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 20.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 23.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 20.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 20.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 23.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 23.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 23.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 26.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 19.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 22.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 23.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 20.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 20.72 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 20.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 23.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 23.47 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 20.18 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 23.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 22.88 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 26.92 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 12.05 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 16.42 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 15.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 13.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 12.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 23.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 14.43 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 12.80 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 23.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 13.12 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 23.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 14.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 13.41 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 15.63 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 23.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 15.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 13.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 15.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 23.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 13.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 15.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 23.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 15.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 23.89 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 15.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 13.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 15.36 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 4.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 13.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 7.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 23.53 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 13.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 7.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 26.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 10.11 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 17.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 12.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 17.02 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 20.48 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 20.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 18.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 17.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 17.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 17.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 17.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 17.65 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 9.60 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 12.12 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 12.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 12.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 11.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 12.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 12.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 12.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 11.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 12.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 8.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 12.28 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 11.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 12.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 11.81 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 11.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 11.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 11.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 11.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 8.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 8.75 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 11.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 10.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 12.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 31.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 23.03 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 25.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 23.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 29.73 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 24.73 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 22.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 23.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 22.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 26.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 22.12 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 23.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 22.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 22.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 22.47 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 22.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 23.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 23.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 22.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 22.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 22.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 22.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 18.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 18.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 15.64 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 18.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 15.90 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 8.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 12.50 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 12.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 16.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 18.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 16.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 12.63 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 17.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 18.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 18.39 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 14.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 16.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 16.67 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 16.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 14.62 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 19.15 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 8.51 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 15.69 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 16.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 18.39 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 28.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 30.77 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 23.08 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 18.92 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 20.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 18.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 6.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 23.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 16.36 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 11.63 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 11.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 10.99 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°22 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 3.06 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 3.39 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 3.97 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 1.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 2.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 2.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 4.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 3.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 3.25 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 3.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 3.47 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 3.25 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 3.01 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 2.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 2.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 2.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 2.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 2.99 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 1.86 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 1.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 2.11 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 1.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 1.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 1.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 1.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 2.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 1.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 1.96 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 3.85 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 2.68 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 3.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 1.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 3.61 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 2.17 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 1.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 3.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 1.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 3.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 1.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 3.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 2.11 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 1.77 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 3.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 4.55 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 3.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 3.19 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 1.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 3.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 2.86 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 1.54 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 3.37 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.20 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 3.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 3.28 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 2.94 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 2.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 1.61 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 2.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 2.22 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 1.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 2.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 1.75 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 1.75 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 2.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 2.31 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 2.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 2.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 2.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 2.21 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 1.52 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 2.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 2.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 2.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 1.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 2.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 2.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.51 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 2.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 2.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 2.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 2.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 3.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.43 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 2.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 5.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 2.24 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 2.99 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 1.75 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 2.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.70 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 2.38 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 1.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.87 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 2.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 1.03 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 1.01 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 1.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 1.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 3.07 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 1.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 1.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 1.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 2.13 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 2.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 3.57 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 2.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 2.52 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 2.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 2.32 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 2.32 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-48 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-49 | 1.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-50 | 1.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-51 | 1.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Weeks 40-52 | 1.10 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°34 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.75 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-42 | 0.49 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-43 | 0.47 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-44 | 0.45 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-45 | 0.33 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-46 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-47 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-48 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-49 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-50 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-51 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 18-65 years,Weeks 40-52 | 0.28 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-49 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | 6 months to 17 years,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category | >65 years,Weeks 40-43 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.80 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-52 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-46 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-46 | 0.21 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-51 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-47 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-42 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-51 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-47 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-52 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-42 | 0.35 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-44 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-50 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-48 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-43 | 0.29 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-50 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-43 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-49 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-44 | 0.26 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-40 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-45 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-41 | 0.00 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-45 | 0.22 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Weeks 40-48 | 0.20 Percentage of subjects |
| Total Group | Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Weeks 40-49 | 0.00 Percentage of subjects |
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Week 46 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Week 47 | 47.37 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Week 48 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Week 49 | 11.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Week 50 | 9.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Week 51 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Week 52 | 25.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 43 | 45.16 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 44 | 55.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 47 | 38.10 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 46 | 26.92 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 42 | 45.39 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 45 | 35.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 46 | 42.31 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 41 | 36.26 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 47 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 40 | 32.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 43 | 38.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 44 | 20.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 42 | 32.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 45 | 66.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 44 | 35.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 42 | 44.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 47 | 70.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 46 | 38.81 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 43 | 47.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 48 | 81.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 45 | 50.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 48 | 81.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 40 | 32.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 41 | 36.26 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 42 | 42.80 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 43 | 45.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 44 | 39.66 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 45 | 47.37 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 46 | 36.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Week 47 | 53.49 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°36 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 29.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 100 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 36.62 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 31.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 57.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 47.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 46.43 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 26.92 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 24.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 9.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 46.15 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 41.46 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 40.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 87.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 32.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 100 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 33.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 66.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 47.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 33.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 47.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 31.03 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 70.59 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 81.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 60.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 55.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 44.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 44.23 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 83.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 46.15 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 25.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 56.96 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 32.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 50.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 26.09 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 47.83 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 41.46 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 44.74 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 46.15 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 81.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 45.65 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 70.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 31.03 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 38.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 47.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 33.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 28.95 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 47.44 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 44.23 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 30.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 35.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 55.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 56.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 44.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 26.92 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 38.10 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 45.16 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 36.36 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 58.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 38.89 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 40.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 30.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 100 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 83.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 36.17 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 34.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 40.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 35.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 56.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 47.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 34.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 52.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 39.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 70.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 76.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 38.89 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 47.37 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 49.21 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 36.84 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 70.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 100 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 42.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 45.51 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 46.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 43.66 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 45.16 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 33.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 43.08 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 100 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 52.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 36.36 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 72.73 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 34.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 76.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 36.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 46.88 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 35.87 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 40.74 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 66.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 50.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 15.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 18.18 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 50.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 38.46 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 42.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 9.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 6.45 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°58 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 3.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 1.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 1.49 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°60 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 2.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 2.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 2.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 1.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 1.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 2.53 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 2.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 2.44 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 2.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 1.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 2.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 4.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 2.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 1.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 2.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 2.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 1.09 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°62 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 2.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 6.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 4.35 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 2.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 2.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 1.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 1.41 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 1.49 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 3.08 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 16.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 9.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 9.68 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 13.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 9.46 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 12.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 15.15 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 2.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 12.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 2.99 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 4.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 13.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 3.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 10.42 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 8.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 10.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 4.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 10.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 2.34 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 12.68 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 11.11 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 10.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 8.06 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 2.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 12.31 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 5.80 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 15.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 2.99 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 9.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 2.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 7.61 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 6.18 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 9.09 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 16.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 9.09 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 50.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 17.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 41.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 37.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 30.40 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 15.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 28.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 19.35 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 27.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 27.78 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 30.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 24.24 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 31.91 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 26.87 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 19.05 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 43.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 23.81 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 17.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 35.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 29.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 50.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 61.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 19.44 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 28.07 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 28.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 26.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 50.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 66.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 28.07 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 29.21 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 26.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 30.99 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 20.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 17.78 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 32.31 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 66.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 30.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 27.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 45.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 26.87 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 61.54 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 31.91 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 34.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 25.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 25.93 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 9.09 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 38.46 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°44 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 9.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 8.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 7.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 6.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 11.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 12.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 12.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 6.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 6.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 8.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 5.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 3.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 6.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 17.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 8.82 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 10.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 1.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 9.62 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 6.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 8.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 6.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 10.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 16.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 4.35 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 12.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 5.26 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 11.54 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 6.52 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 17.65 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 6.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 9.88 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 3.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 6.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 5.26 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 5.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 1.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 5.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 9.46 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 6.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 9.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 8.51 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 8.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 7.14 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 4.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 4.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 6.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 10.42 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 5.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 4.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 5.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.58 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 7.87 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 5.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 7.04 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 6.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 6.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 4.62 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 5.80 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 9.09 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 18.18 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 8.96 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 15.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 8.51 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 6.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 8.70 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 3.70 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 50.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°64 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 12.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 1.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 1.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°66 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 1.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 16.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 2.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 1.23 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 1.61 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 3.08 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°46 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 4.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 2.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 2.44 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 11.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 6.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 2.44 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 6.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 6.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 11.54 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 3.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 5.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 10.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 2.63 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 3.70 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 2.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 4.05 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 2.13 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 2.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 4.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 17.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 4.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 2.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 14.04 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 3.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.58 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 3.93 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 13.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 7.04 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 1.61 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 2.22 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 3.08 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 2.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 15.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 2.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 3.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 1.09 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 9.09 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°48 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 11.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 20.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 12.90 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 11.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 12.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 30.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 12.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 4.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 21.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 20.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 6.82 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 8.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 1.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 3.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 3.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 5.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 37.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 14.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 15.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 6.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 13.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 4.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 20.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 2.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 11.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 12.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 7.89 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 3.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 37.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 15.22 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 5.88 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 3.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 12.35 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 3.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 1.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 10.53 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 5.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 10.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 19.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.25 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 11.54 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 3.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 12.77 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 5.97 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 2.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 4.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 4.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 8.70 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 8.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 46.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 5.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 8.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 7.94 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 10.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 9.94 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 10.11 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 10.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 12.68 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 4.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 2.22 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.15 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 8.70 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 2.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 9.09 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 5.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 46.15 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 12.77 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 3.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 9.78 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 14.81 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°50 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 14.08 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 10.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 4.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 17.14 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 11.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 12.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 6.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 4.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 12.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 4.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 28.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 100 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 5.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 1.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 3.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 5.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 37.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 14.71 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 16.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 13.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 4.55 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 10.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 4.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 16.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 4.35 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 8.70 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 12.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 7.89 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 37.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 5.88 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 13.04 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 3.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 5.75 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 13.58 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 1.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 1.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 17.31 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 9.68 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 16.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 13.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 3.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 9.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.06 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 100 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 5.97 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 6.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 9.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 4.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 7.61 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 8.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 38.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 2.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 7.02 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 12.70 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 10.53 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 33.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 5.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 9.09 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 13.04 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 38.46 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 11.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 14.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 9.68 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 18.18 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 9.23 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 33.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 6.52 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 2.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 6.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 6.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 10.11 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°52 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 1.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 2.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 10.34 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 5.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 3.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 1.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 6.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 5.88 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 1.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 6.52 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 2.63 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 2.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 5.88 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 6.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 1.23 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 1.15 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 3.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 2.63 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 5.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 1.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 12.12 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 2.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 4.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 2.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 2.78 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 7.02 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 1.59 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 5.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.58 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 6.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 2.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 1.61 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 2.22 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 6.15 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 1.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 3.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 2.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 3.70 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 10.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 9.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°54 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 11.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 21.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 10.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 25.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 9.68 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 17.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 14.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 6.90 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 17.07 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 20.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 14.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 20.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 4.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 25.64 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 18.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 22.99 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 17.24 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 35.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 31.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 19.12 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 23.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 26.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 21.15 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 4.55 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 18.99 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 10.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 20.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 8.70 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 10.14 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 17.07 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 18.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 15.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 31.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 19.57 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 35.29 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 17.24 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 20.99 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 22.99 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 18.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 5.26 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 25.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 26.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 10.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 20.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 12.50 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 9.60 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 9.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 19.35 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 9.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 9.09 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 17.02 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 8.96 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 30.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 16.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 31.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 28.57 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 21.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 20.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 20.83 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 30.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 23.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 25.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 24.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 22.22 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 21.05 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 30.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 66.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 12.87 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 20.79 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 23.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 21.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 24.19 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 15.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 15.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 66.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 21.74 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 9.09 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 27.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 8.96 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 23.08 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 17.02 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 15.63 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 15.22 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 14.81 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 15.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 9.09 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 36.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°56 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 7.04 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 3.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 3.45 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 10.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 2.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 4.55 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 3.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 2.30 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 3.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 1.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 4.55 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 2.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 2.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 5.26 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 6.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 2.30 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 3.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 3.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 6.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 12.50 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 3.03 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 2.99 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 2.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 4.35 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 2.17 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 3.93 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 1.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 1.41 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 1.61 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 2.22 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 4.62 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 2.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 2.99 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 3.70 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | At risk,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 48 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status | Not at risk,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°68 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.80 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 42 | 0.58 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | At risk,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status | Not at risk,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed.
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tachycardia,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 2.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tinnitus,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 2.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 45 | 0.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 1.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vertigo,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pain,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear haemorrhage,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear pruritus,Week 44 | 0.86 Percentage of subjects |
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye discharge,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Eye pruritus,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lacrimation increased,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Swelling of eyelid,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 10.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Week 47 | 10.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Eye pruritus,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 47 | 9.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 43 | 6.45 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 9.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 9.46 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 13.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 9.68 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 45 | 5.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 42 | 2.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 45 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 2.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 2.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 11.63 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 40 | 2.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 41 | 2.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 42 | 6.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 45 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 43 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 42 | 5.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 43 | 2.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 48 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 45 | 1.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 8.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 46 | 1.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 4.62 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 46 | 5.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 3.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 10.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 43 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 43 | 5.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 45 | 3.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 46 | 5.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 45 | 1.94 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 48 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 46 | 1.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 6.07 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 46 | 5.04 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 46 | 4.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 8.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 9.30 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 40 | 2.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 48 | 6.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 41 | 2.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 47 | 6.98 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 42 | 2.12 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 44 | 2.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 43 | 2.46 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 43 | 4.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 42 | 2.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 48 | 6.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 44 | 3.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 43 | 3.28 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 43 | 3.28 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 42 | 1.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Diarrhoea,Week 45 | 3.24 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 44 | 4.31 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tongue discomfort,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 45 | 2.02 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 2.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 2.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nausea,Week 45 | 2.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Vomiting,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 5.08 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal discomfort,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Stomatitis,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Gingival bleeding,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 9.02 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Abdominal pain,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Lip swelling,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 7.76 Percentage of subjects |
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 10.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 2.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Week 46 | 33.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Week 50 | 2.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Diarrhoea,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nausea,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Vomiting,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Abdominal pain,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°38 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 5.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 9.86 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 10.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 14.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 1.61 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 10.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 14.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 10.34 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 25.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 4.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 2.27 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 8.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 3.33 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 5.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 6.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 11.76 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 1.47 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 13.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 11.54 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 2.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 3.80 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 4.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 20.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 16.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 8.70 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 2.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 7.89 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 3.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 10.87 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 11.76 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 6.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 8.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 5.75 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 3.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 5.26 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 8.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 10.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 17.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 31.21 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 15.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 42 | 2.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 44 | 11.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 28.57 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 45 | 4.05 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 47 | 14.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 42 | 28.37 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 43 | 16.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 19.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 44 | 22.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 45 | 10.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 47 | 14.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 42 | 4.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 44 | 5.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 43 | 12.90 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 47 | 14.29 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 41.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 44 | 13.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 29.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 40 | 8.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 41 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 42 | 11.63 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 25.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 46 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 41 | 3.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 45 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 40 | 17.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 41 | 18.68 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 42 | 11.63 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 40 | 2.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 44 | 13.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 20.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 45 | 33.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 46 | 11.54 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 40 | 11.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 41 | 9.89 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 26.92 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 41 | 6.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 42 | 9.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 42 | 9.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 25.58 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 43 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 44 | 13.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 44 | 6.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 18.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 32.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 28.36 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 50.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 62.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 43 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 45 | 1.94 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 46 | 5.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 43 | 1.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 43 | 8.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 44 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 45 | 6.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 46 | 10.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 47 | 15.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 42 | 5.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 43 | 6.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 45 | 5.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 46 | 5.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 48 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 42 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 43 | 6.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 44 | 6.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 45 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 46 | 17.91 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 47 | 30.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 48 | 62.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 42 | 5.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 43 | 6.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 45 | 6.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 46 | 8.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 47 | 20.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 48 | 18.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 42 | 5.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 43 | 12.82 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 45 | 4.52 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 46 | 7.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 48 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 46 | 1.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 46 | 1.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 47 | 4.65 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 23.77 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 48 | 6.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 46 | 4.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 46 | 5.04 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 45 | 2.83 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 44 | 2.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 43 | 8.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 45 | 2.02 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 42 | 1.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 29.24 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pyrexia,Week 40 | 2.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 48 | 18.75 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 47 | 16.28 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 46 | 9.24 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 45 | 1.21 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 45 | 6.07 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 44 | 3.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 43 | 7.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 42 | 5.93 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 44 | 2.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pruritus,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 41 | 9.89 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site swelling,Week 40 | 11.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 48 | 62.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 47 | 20.93 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 43 | 2.46 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 46 | 13.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 45 | 18.22 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 44 | 12.07 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 43 | 9.02 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 42 | 1.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 42 | 22.46 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 41 | 18.68 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 41 | 3.30 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site pain,Week 40 | 17.14 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 48 | 6.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 47 | 6.98 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 46 | 6.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site warmth,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 45 | 4.05 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 44 | 5.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 43 | 4.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 42 | 3.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 62.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 41 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site erythema,Week 40 | 8.57 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 29.67 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 47 | 9.30 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 46 | 6.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 45 | 6.48 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 37.21 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 44 | 9.48 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 43 | 8.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 25.21 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 42 | 4.24 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 41 | 6.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 25.71 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Malaise,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Fatigue,Week 40 | 5.71 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 29.55 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 25.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 43 | 0.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling hot,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 46 | 1.68 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Face oedema,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Influenza like illness,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Feeling cold,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Peripheral swelling,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mucous membrane disorder,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Chills,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Injection site haematoma,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Discomfort,Week 42 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 36.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Chills,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Face oedema,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Week 51 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Fatigue,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site erythema,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Week 47 | 31.58 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site pain,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Injection site swelling,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Week 47 | 10.53 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Week 49 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Week 50 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Pyrexia,Week 52 | 25.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°40 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 17.65 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 100 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 18.31 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 21.05 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 42.86 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 33.06 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 21.43 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 15.38 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 42.86 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 17.24 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 9.09 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 42.31 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 50.00 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 36.59 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 10.00 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 62.50 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 24.00 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 35.71 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 40.00 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 15.91 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 33.33 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 16.67 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 66.67 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 26.92 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 16.67 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 24.14 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 24.14 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 47.06 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 62.50 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 40.00 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 44.12 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 31.58 percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 26.92 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 66.67 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 32.69 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 15.91 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 44.30 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 24.00 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 40.00 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 16.67 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 17.39 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 34.06 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 36.59 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 18.42 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 42.31 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 62.50 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 34.78 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 47.06 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 24.14 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 20.99 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 24.14 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 16.67 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 15.79 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 26.92 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 26.92 percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 20.00 percentage of subjects |
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hypersensitivity,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Anaphylactic reaction,Week 43 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and \>65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°42 for the overall (across age strata) post-dose 2 results.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 1.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 6 months to 17 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | 18-65 years,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 45 | 1.23 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category | >65 years,Week 41 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 44 | 5.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 9.46 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 44 | 5.56 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 6.45 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 45 | 8.11 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 41 | 3.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 8.79 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 41 | 6.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 8.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 46 | 4.48 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 5.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 6.15 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 5.81 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 8.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 15.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 43 | 1.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 45 | 3.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 46 | 5.97 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 48 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 43 | 2.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 45 | 2.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 48 | 6.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 43 | 1.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 41 | 3.30 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 8.79 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 43 | 0.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 40 | 4.29 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Ear infection,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 9.30 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 7.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasopharyngitis,Week 48 | 6.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Bronchitis,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 8.57 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 46 | 2.52 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 45 | 3.24 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 44 | 4.31 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 7.29 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 43 | 2.46 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 42 | 1.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 6.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 41 | 6.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinitis,Week 40 | 4.29 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 48 | 6.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 47 | 4.65 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 5.74 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oral herpes,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 46 | 5.88 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 45 | 4.45 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hordeolum,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 44 | 2.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 43 | 2.46 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 1.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Upper respiratory tract infection,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Herpes simplex,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Conjunctivitis,Week 42 | 1.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Laryngitis,Week 46 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 2.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Week 48 | 8.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Week 50 | 2.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Conjunctivitis,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinitis,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 45 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Muscle strain,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 42 | 0.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 43 | 0.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Heart rate increased,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for investigations.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card was decreased appetite.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 4.05 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 45 | 4.05 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 45 | 3.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 43 | 11.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 44 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 11.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 3.87 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 42 | 1.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 5.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 1.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 43 | 7.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 44 | 5.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 45 | 3.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Decreased appetite,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 3.64 Percentage of subjects |
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card was decreased appetite.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 2.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Week 50 | 2.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Decreased appetite,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 11.54 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 42 | 9.93 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 45 | 9.46 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 11.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 46 | 11.54 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 19.44 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 42 | 1.42 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 10.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 44 | 13.89 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 23.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 41 | 2.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 45 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 43 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 45 | 5.56 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 41 | 5.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 16.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 43 | 6.41 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 46 | 1.49 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 45 | 6.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 46 | 7.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 37.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 48 | 31.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 43 | 1.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 45 | 3.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 8.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 8.39 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 48 | 18.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 5.71 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 8.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.38 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 8.62 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 9.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 10.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 4.65 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 37.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 41 | 2.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 42 | 1.27 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 43 | 1.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 44 | 5.17 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 45 | 3.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 46 | 3.36 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 47 | 4.65 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Arthropathy,Week 48 | 18.75 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 40 | 5.71 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 41 | 5.49 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 42 | 7.63 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 43 | 4.92 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 44 | 4.31 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 45 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 46 | 8.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Myalgia,Week 48 | 31.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Limb discomfort,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Musculoskeletal pain,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 43 | 0.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pain in extremity,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rheumatic disorder,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Synovial cyst,Week 48 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Arthropathy,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Myalgia,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 13.51 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 45 | 10.81 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 44 | 16.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 42 | 4.96 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 43 | 9.68 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 9.68 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 16.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 5.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 41 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 46 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 47 | 50.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 37.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 8.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 9.68 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 45 | 7.74 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 46 | 8.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 48 | 37.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 45 | 8.91 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 4.65 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 4.66 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 46 | 8.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 8.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 47 | 4.65 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 48 | 37.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 10.93 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 6.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 42 | 4.24 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 45 | 1.21 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 8.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Somnolence,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 5.71 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Aphonia,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 43 | 8.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dizziness,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 41 | 7.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 44 | 6.90 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 37.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Headache,Week 40 | 4.29 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Poor quality sleep,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Febrile convulsion,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Tremor,Week 43 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 42 | 6.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 9.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 43 | 5.13 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 46 | 2.99 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 2.99 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 5.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 2.12 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 4.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 2.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 2.52 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 42 | 1.69 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 43 | 4.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 44 | 2.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 45 | 0.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 46 | 2.52 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Irritability,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Insomnia,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Mood swings,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sleep disorder,Week 47 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 8.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 5.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Week 48 | 8.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Week 49 | 5.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Irritability,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 9.52 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 42 | 1.42 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 42 | 2.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 43 | 6.45 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 42 | 3.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 45 | 5.41 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 47 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 45 | 16.22 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 44 | 16.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 43 | 16.13 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 42 | 3.55 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 42 | 2.84 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 9.93 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 19.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 44 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 25.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 44 | 2.78 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 20.27 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 41 | 5.49 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 42 | 6.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 8.57 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 13.19 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 9.30 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 23.08 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 22.22 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 41 | 2.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 40 | 7.14 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 41 | 2.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 40 | 4.29 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 41 | 6.59 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 42 | 6.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 43 | 15.38 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 42 | 6.98 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 45 | 11.11 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 40 | 5.71 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 41 | 2.20 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 42 | 4.65 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 44 | 6.67 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 45 | 5.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 18.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 25.64 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 45 | 2.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 26.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 44 | 9.23 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 43 | 2.56 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 48 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 43 | 1.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 43 | 1.28 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 42 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 42 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 43 | 10.26 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 48 | 18.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 44 | 10.77 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 48 | 12.50 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 46 | 8.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 45 | 10.32 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 47 | 5.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 47 | 10.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 46 | 8.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 46 | 8.96 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 47 | 15.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 48 | 18.75 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 44 | 1.54 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 45 | 6.45 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 44 | 12.31 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 45 | 2.58 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 46 | 7.46 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 43 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 42 | 15.38 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 45 | 5.16 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 31.25 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 30.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 20.90 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 21.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 46 | 1.49 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 40 | 4.29 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 42 | 2.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 43 | 2.46 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 45 | 2.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dysphonia,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 41 | 2.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 43 | 1.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 45 | 1.62 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Epistaxis,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 40 | 5.71 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 41 | 2.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 42 | 5.93 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 43 | 6.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 44 | 8.62 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 45 | 4.05 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 46 | 5.04 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Nasal congestion,Week 48 | 12.50 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 40 | 5.71 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 41 | 5.49 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 42 | 3.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 43 | 5.74 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 44 | 2.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 45 | 4.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 46 | 5.88 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Oropharyngeal pain,Week 48 | 18.75 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 40 | 4.29 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 41 | 6.59 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 42 | 5.08 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 43 | 10.66 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 44 | 11.21 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 45 | 12.15 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 46 | 7.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 47 | 6.98 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rhinorrhoea,Week 48 | 18.75 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 42 | 0.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 43 | 1.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 44 | 1.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Wheezing,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 44 | 0.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dry throat,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 42 | 0.85 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 43 | 0.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Dyspnoea,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 43 | 0.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Increased upper airway secretion,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 43 | 0.82 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 44 | 1.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Sneezing,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 47 | 2.33 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Throat clearing,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 8.57 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 13.19 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 13.56 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 23.77 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 18.97 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 21.05 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 15.13 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 18.60 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 31.25 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 40 | 7.14 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 41 | 2.20 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 42 | 5.93 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 43 | 11.48 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 44 | 7.76 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 45 | 6.48 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 46 | 5.04 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Cough,Week 47 | 6.98 Percentage of subjects |
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Week 50 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Week 48 | 8.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Dysphonia,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Epistaxis,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Week 48 | 12.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Week 49 | 2.94 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Nasal congestion,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Oropharyngeal pain,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Week 48 | 20.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Week 49 | 5.88 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Week 50 | 2.38 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Week 51 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rhinorrhoea,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Week 47 | 5.26 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Wheezing,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Week 51 | 8.33 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Sneezing,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 15.79 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 36.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 8.82 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 4.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 16.67 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Week 47 | 15.79 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Week 48 | 20.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Cough,Week 49 | 8.82 Percentage of subjects |
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 45 | 1.35 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 6.76 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 45 | 2.70 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 3.23 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 7.69 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 2.33 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 1.10 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 2.86 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 46 | 3.85 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 40 | 1.43 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 3.85 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 1.29 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 42 | 1.92 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 44 | 3.08 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 45 | 0.65 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 45 | 0.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 1.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 43 | 1.64 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 1.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 2.83 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.84 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 40 | 1.43 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hyperhidrosis,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 44 | 1.72 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 45 | 0.40 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 45 | 0.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 45 | 0.81 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Rash generalised,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 42 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 2.86 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus generalised,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 1.10 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Pruritus,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Erythema,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 1.27 Percentage of subjects |
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Any,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Week 48 | 4.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash,Week 52 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Week 49 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Week 50 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Week 51 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | Rash generalised,Week 52 | 0.00 Percentage of subjects |
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.
Time frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.71 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 40 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 41 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Influsplit Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 48 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 44 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 47 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 43 | 0.00 Percentage of subjects |
| Vaccinated_Fluarix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 48 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 40 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 41 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 42 | 0.42 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 43 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 44 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 45 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 46 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Hot flush,Week 47 | 0.00 Percentage of subjects |
| Total Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall | Any,Week 42 | 0.42 Percentage of subjects |
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.
Time frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days
Population: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccinated_AlphaRix Tetra Group | Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group | 0 Percentage of subjects |